Generic Name: ezetimibe and simvastatin (ez ET i mibe and SIM va stat in)Brand Names: Vytorin
Ezetimibe and simvastatin are cholesterol-lowering medicines. They reduce the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.
The combination of ezetimibe and simvastatin lowers "bad" cholesterol in the blood, (also called LDL, or low-density lipoprotein) and raises "good" cholesterol (also called HDL, or high-density lipoprotein). Lowering your LDL and raising your HDL cholesterol levels may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.
Ezetimibe and simvastatin may also be used for other purposes not listed in this medication guide.What is the most important information I should know about ezetimibe and simvastatin?
Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured with blood tests at regular intervals. Do not miss any scheduled visits to your doctor. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?You should not use this medication if you are allergic to ezetimibe (Zetia) or simvastatin (Zocor), or if you have:
liver disease; or
if you are pregnant or breast-feeding.
Before taking ezetimibe and simvastatin, tell your doctor if you are allergic to any drugs, or if you have:
an underactive thyroid;
a muscle disorder; or
if you use steroid medicine or hormones (including birth control pills).
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. FDA pregnancy category X. This medication can cause birth defects. Do not use ezetimibe and simvastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether ezetimibe and simvastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 10 years old.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Ezetimibe and simvastatin is usually taken once daily in the evening with or without food. Follow your doctor's instructions.It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured with blood tests at regular intervals. Do not miss any scheduled visits to your doctor.
Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.Store ezetimibe and simvastatin at room temperature away from moisture and heat.
See also: Ezetimibe and simvastatin dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
An overdose of ezetimibe and simvastatin is not expected to produce life-threatening symptoms.
Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
If you take another cholesterol-lowering medication such as cholestyramine (Locholest, Prevalite, Questran), colestipol (Colestid), or colesevelam (Welchol), take your ezetimibe and simvastatin dose at least 2 hours before or 4 hours after the other medication(s).
Grapefruit and grapefruit juice may interact with ezetimibe and simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.Avoid drinking alcohol while taking ezetimibe and simvastatin. Alcohol may increase your risk of liver damage. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ezetimibe and simvastatin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes);
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
easy bruising or bleeding; or
Less serious side effects may include:
numbness or tingly feeling;
headache, dizziness, memory problems;
cough, sore throat, runny or stuffy nose;
joint pain, back pain; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Hyperlipidemia:
Initial dose: 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening. The dosage range is 10 mg-10 mg to 10 mg-80 mg per day. Initiation of therapy with 10 mg-10 mg per day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10 mg-40 mg per day.Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response.
Usual Adult Dose for Homozygous Familial Hypercholesterolemia:
Initial dose: 10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.This dose may be titrated to 10 mg-80 mg orally once a day in the evening.
Many drugs can interact with ezetimibe and simvastatin. Below is just a partial list. Tell your doctor if you are using:
amiodarone (Cordarone, Pacerone);
cholestyramine (Questran), colestipol (Colestid), or colesevelam (Welchol);
cyclosporine (Sandimmune, Neoral);
digoxin (Lanoxin, Lanoxicaps);
gemfibrozil (Lopid), fenofibrate (Tricor) or clofibrate (Atromid-S);
niacin (Nicolar, Nicobid, Slo-Niacin, others);
verapamil (Calan, Covera-HS, Isoptin, Verelan);
a blood thinner such as warfarin (Coumadin);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, others), itraconazole (Sporanox), ketoconazole (Nizoral), or telithromycin (Ketek); or
HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), or tipranavir (Aptivus).
This list is not complete and there may be other drugs not listed that can affect ezetimibe and simvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.